Sidekick vs Conventional Cannula in Lumbar Medial Branch Radiofrequency Ablation

NCT07475689 | Completed

• 1 other identifier: AEŞH-BADEK-2024-1021
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar facet joint-mediated chronic low back pain is a common cause of disability. Radiofrequency ablation (RFA) of the lumbar medial branches is an established interventional pain treatment. Different cannula designs may influence lesion geometry and clinical outcomes. This prospective randomized study aims to compare the clinical outcomes of conventional cannulas and sidekick cannulas used during lumbar medial branch radiofrequency ablation. Patients with chronic lumbar facet joint pain who meet inclusion criteria will be randomly assigned to receive RFA using either a conventional cannula or a sidekick cannula technique. The primary objective is to evaluate pain reduction following the procedure. Secondary outcomes include functional improvement and duration of pain relief during follow-up.

Conditions

Facet Joint Pain; Low Back Pain

Keywords

Back pain; Facet joint pain; Sidekick cannula; Chronic back pain

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity (Numeric Rating Scale)

  Change in pain intensity measured by Numeric Rating Scale (NRS) Pain intensity will be measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.

  Baseline to 6 months

Secondary Outcomes (1)

• Functional improvement

  6 months

Study Arms (2)

Conventional Cannula

ACTIVE COMPARATOR

Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula.

Procedure: Lumbar Medial Branch Radiofrequency Ablation; Drug: Triamcinolone (20 g); Drug: bupivacain 0.5% 2ml; Device: conventional radiofrequency cannul

Sidekick Cannula

EXPERIMENTAL

Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula.

Procedure: Lumbar Medial Branch Radiofrequency Ablation; Drug: Triamcinolone (20 g); Drug: bupivacain 0.5% 2ml; Device: sidekick radiofrecueny cannula

Interventions

Lumbar Medial Branch Radiofrequency Ablation PROCEDURE

Lumbar medial branch radiofrequency ablation performed for chronic lumbar facet-mediated pain. The procedure is performed under fluoroscopic guidance .

Conventional Cannula; Sidekick Cannula

Triamcinolone (20 g) DRUG

Triamcinolone acetonide administered after ablation as part of the post-procedural injection mixture.

Conventional Cannula; Sidekick Cannula

bupivacain 0.5% 2ml DRUG

Bupivacaine 0.5% administered after ablation as part of the post-procedural injection mixture.

Conventional Cannula; Sidekick Cannula

conventional radiofrequency cannul DEVICE

standard straight radiofrequency cannula used during lumbar medial branch radiofrequency ablation

Conventional Cannula

sidekick radiofrecueny cannula DEVICE

sidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation

Sidekick Cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Chronic lumbar facet-mediated low back pain lasting more than 3 months
• Failure of conservative treatment including physical therapy and medical management
• Positive diagnostic medial branch block
• Patients scheduled for lumbar medial branch radiofrequency ablation

You may not qualify if:

• Previous lumbar radiofrequency ablation at the same level
• Coagulopathy or anticoagulant therapy that cannot be discontinued
• Local infection at the procedure site
• Severe spinal deformity or instability
• Pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Gulhane Training and Research Hospital, Department of Anesthesiology and Reanimation

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind randomized study. Participants and outcome assessors are blinded to the cannula type used during lumbar medial branch radiofrequency ablation. The physician performing the procedure is aware of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 16, 2026
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 24, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)